Production & Process Control Pops Up In Most 2015 Warning Letters; OUS Firms Corner Market On P&PC Problems, FDA Official Says
This article was originally published in The Gray Sheet
FDA's production and process control requirements continue to dog the medical device industry, yet agency official Sean Boyd says an overall uptick in P&PC violations is primarily due to FDA's abbreviated Level 1 inspection technique, which will almost always include P&PC scrutiny by agency investigators. But two industry experts – including a longtime FDA veteran – say problems with production and process controls run much deeper than a simple audit approach. Meanwhile, the agency's national device expert says manufacturers – typically ones outside the US – struggle most with P&PC. "One thing we have been seeing, and it's been happening with the foreign inspections quite a bit, is an entire lack of process validation," he says.
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